Reportedly, 63 percent of U.S. prescriptions are now generics, up from 18.6 percent in 1984. Given the controversy surrounding this high rate of generic prescription drug use, Blaise Bourgeois, MD, director of the Division of Epilepsy and Clinical Neurophysiology at Children's Hospital Boston, is actively looking into the issues. Here, he presents different sides of the argument.
How do you see the problem?
There's a disagreement between the FDA and physicians/patient advocacy groups who aren't sure generics are safe and don't
consider current bioequivalence rules adequate. Between them are several groups with financial interests: companies selling brand-name drugs, those selling generic drugs, pharmacies and third-party payors. Basically, there are problems on both sides since neither has provided scientific proof and both are susceptible to influence through lobbying, political pressures or financial incentives.
What made you look into this issue?
It's something I'm confronted with every day. I'm in the business of treating patients with epilepsy so I need to know what drugs
are effective for them. Pharmacies have mandatory substitution rules to switch patients to generics unless a doctor writes 'brand medically necessary' on the prescription. So either I let the
pharmacists switch to generics or I don't. But I don't just request no substitutions because the next time we renegotiate with our insurers, they'll say we're prescribing too many brand names.
Do you often write "brand medically necessary?"
I did it two or three times just this week. With those patients,
I feel compelled to because God forbid the child comes into the
ED harmed by a seizure unrelated to the drug. I'd be in terrible trouble. How are you going to prove you did the right thing? So in a way it's defensive medicine. On the other hand, just yesterday, I switched a patient from brand name to generic. The father asked me, "Isn't generic cheaper?" and I said that it was. He asked if generics are a problem and I said, "In general, no."
Is there a reason for concern regarding generic
antiepileptic drug (AED) regulations?
Definitely. Regulatory agencies established universal bioequivalence rules and never provided scientific evidence that they're safe for all classes of medications, diseases and patient populations. The FDA says generics need a 90 percent confidence level that the generic is within 80 percent below or 125 percent above the brand name's absorption rate. Much of the controversy centers on the safety and efficacy of patients being switched from brand to generic drugs. However, the main flaw I see in the current regulations isn't changing them from brand to generic or starting and maintaining a patient on a generic. It's changing them from generic A (125 percent) to generic E (80 percent), which is a pretty big margin.
Is the concern about generics' safety exaggerated?
Probably. The FDA points out, correctly, that the chance that
someone would go from 125 above brand to 80 below brand is extremely low. Also, there's never been a controlled study, so reports of patients experiencing problems coinciding with
substitutions are all anecdotal. How can any side be so vocal if there's no strong data? Controlled studies could very well show
the problem is limited to a small group of identifiable patients.
How could this be resolved with clinical studies?
Randomized double-blind studies would either reassure patients and physicians that current generic policies are safe or they'd
provide the regulatory agencies with data they need to justify
readjustments or policies and identify groups of patients at risk.
Could opinions for or against generics be amplified by those with financial interests?
Definitely. It's quite obvious there's a lot of lobbying going on and a lot of trying to manipulate opinions. It's currently very political at the state level, as reps are being lobbied by patient and physician groups with the support of brand-name pharmaceutical companies. It's been well shown that drug companies are financing many of these patient advocacy groups and that there are huge monetary contributions to these groups from companies with financial stakes. Those same contributions to regulatory agencies would be illegal. So the physician and advocacy groups are rightly criticized for being manipulated and bought by the brand-name companies. There's no doubt in my mind that a lot of the controversy around generics has been generated and kept alive by the brand-name companies.
I'm sure the generic companies aren't more honest or are more saintly than the brand-name companies, it's just that brand-names are very active. Nor can you trust insurance companies because it's obvious they're guided by saving money, not by science.
Do you think restrictions should be implemented in doctor-industry relationships?
It's hard to say what's wrong because you have to look at society in general. Look what's going on with all the lobbying of politicians in Washington. How can we say that's OK but it's not OK for
pharmaceutical companies to lobby doctors? You can't ask the pharmaceutical industry to be saints when nobody else is. That said, I do think there should be restrictions to prevent doctors from being so manipulated. For example, any given company knows exactly how many prescriptions I've written for each product.
They know how much any doctor prescribes and I think that's absolutely egregious.